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US 12,648,914 B2Granted
Injectable sustained release composition and method of using the same for treating inflammation in joints and pain associated therewith
AssigneeEupraxia Pharmaceuticals USA LLC
InventorsJames A. Helliwell, Amanda M. Malone, Thomas J. Smith, Marc M. Baum
Life of this patent
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Abstract
Described herein are injectable corticosteroid-loaded microparticles, pharmaceutical composition thereof and methods for reducing inflammation or pain in a body compartment such as a joint, an epidural space, a vitreous body of an eye, a surgically created space, or a space adjacent to an implant.
Claims6
A unit dosage form comprising:
- a plurality of microparticles, each microparticle including:
- (1) a crystalline drug core of more than 70% by weight of the microparticle;
- and
- (2) a polymeric shell encapsulating the crystalline drug core,
- wherein the crystalline drug core consists of one or more crystals of a corticosteroid selected from fluticasone, fluticasone furoate, and fluticasone propionate, and the polymeric shell is polyvinyl alcohol (PVA) and is in contact but immiscible with the crystalline drug core;
- wherein the plurality of microparticles have a mean diameter in the range of 50 μm to 150 μm and a standard deviation of less than 50% of the mean diameter;
- and
- wherein the plurality of microparticles are heat-treated at 210-230° C. for at least one hour and the unit dosage form releases the corticosteroid over a period of 2-12 months while maintaining a minimum therapeutically effective concentration of the corticosteroid within a body compartment.
5 more elements
An extended release formulation comprising a plurality of microparticles having a core/shell morphology and been heat-treated at 210-230° C. for at least one hour, wherein each microparticle includes:
- (1) a crystalline drug core of more than 70% by weight of the microparticle, wherein the crystalline drug core consists of one or more crystals of fluticasone, a salt or ester thereof;
- and (2) a polymeric shell encapsulating the crystalline drug core, whereby the polymeric shell is PVA and is in contact but immiscible with the crystalline drug core, wherein said plurality of microparticles have a mean diameter of between 80 μm and 150 μm.
Dependencies are inferred from the claim text.